CLINICAL TRIALS PROFILE FOR ZULRESSO
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All Clinical Trials for ZULRESSO
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT04273191 ↗ | A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone) | Withdrawn | Sage Therapeutics | Phase 4 | 2020-02-01 | In this Phase 4 study, women who have been prescribed commercial ZULRESSO™ (brexanolone) by a physician as standard of care for postpartum depression (PPD) and who are planning to receive the infusion per United States Prescribing Information (USPI) at a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare center are being asked to participate to collect data on multimodal neuroimaging parameters in order to evaluate the relationship between changes in depressive symptoms and changes in neuroimaging parameters. |
| NCT04537806 ↗ | A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19 | Terminated | Sage Therapeutics | Phase 3 | 2020-12-18 | The purpose of this study is to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19. |
| NCT05059600 ↗ | A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting | Not yet recruiting | Sage Therapeutics | Phase 4 | 2021-11-01 | The primary purpose of this study is to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting. |
| NCT05223829 ↗ | Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder | Not yet recruiting | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 1 | 2022-03-01 | For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). |
| NCT05223829 ↗ | Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder | Not yet recruiting | Sage Therapeutics | Phase 1 | 2022-03-01 | For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). |
| NCT05223829 ↗ | Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder | Not yet recruiting | Yale University | Phase 1 | 2022-03-01 | For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). |
| NCT05254405 ↗ | An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder | Not yet recruiting | Sage Therapeutics | Phase 4 | 2022-03-01 | Open-label study of brexanolone infusion for the treatment of posttraumatic stress disorder in 20 adult women with PTSD. Primary Objective: To determine if brexanolone injection infused intravenously for 60 hours at up to 90 μg/kg/h reduces PTSD symptom severity in a group of non-veteran adult female subjects diagnosed with PTSD as assessed by the change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score and rate of remission at 12-weeks post infusion. Secondary Objectives - To evaluate the safety and tolerability profiles of brexanolone in this PTSD patient population as assessed by the incidence of adverse events (AEs), vital sign measurement, the Stanford Sleepiness Scale (SSS) and the Columbia Suicide Severity Rating Scale (C-SSRS). - To determine the effects of brexanolone in reducing depressive symptoms and improving functional capacity in PTSD patients as assessed by change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score and Sheehan Disability Scale scores |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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